Cook Inc.: Medical Device Recall in 2020 - (Recall #: Z-1940-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Number (GPN) G56611 Balloon-expandable stent made of 316L stainless steel with a slotted tube configuration. It is pre-mounted on an over-the-wire balloon catheter, which serves as the delivery system. The stent is positioned between two radiopaque marker bands, which are located inside the balloon at the proximal and distal tapers of the balloon.

Product Classification:

Class II

Date Initiated: April 15, 2020

Date Posted: May 20, 2020

Recall Number: Z-1940-2020

Event ID: 85456

Reason for Recall:

The firm received complaints on five devices from one specific lot where the stent dislodged from the balloon delivery system prior to deployment. Use of affected product may lead to increased procedural time and additional intervention to remove a stent that dislodged within an unintended location.

Status: Terminated

Product Quantity: 10

Code Information:

Lot number 10153876

Distribution Pattern:

Domestic distribution to OH, IA, VA, and NC. Foreign distribution to Canada.

Voluntary or Mandated:

Voluntary: Firm initiated